Why The PolyPid Stock Increased 10.2% (PYPD)

By Amit Chowdhry ● Jan 25, 2023
  • The stock price of PolyPid (PYPD) increased by 10.2% in the most recent trading session. This is why.

The stock price of PolyPid (PYPD) increased by 10.2% in the most recent trading session.

Why: PolyPid provided a positive regulatory update for D-PLEX100 for the prevention of abdominal colorectal surgical site infections (SSIs). And following a recent type D meeting communication with the U.S. Food and Drug Administration (FDA) on the SHIELD I Phase 3 data, the Company now has clarity regarding the regulatory pathway toward a potential New Drug Application (NDA) submission.

PolyPid provided the FDA with currently available data from the SHIELD I study evaluating D-PLEX100 for the prevention of abdominal colorectal SSIs. And based on the data, particularly the 54% reduction observed in the primary endpoint in complex surgeries in a pre-specified subgroup analysis of patients with large incisions (>20 cm) (p=0.0032, n=423) compared to standard of care, the FDA acknowledged that the SHIELD I results may provide supportive evidence on this population and recommended that the Company conduct an additional study to support a potential NDA submission.

The FDA stated that the ongoing SHIELD II study, which to date has enrolled more than 200 patients, could potentially serve as such a study. And PolyPid is now working expeditiously to finalize the design of the revised SHIELD II trial and expects to resume patient recruitment next quarter.


“We are pleased with the outcome of our recent interactions with the FDA and are grateful to the Agency for their supportive feedback. We now have a clear regulatory pathway for the possible approval of D-PLEX100 in United States, and we remain highly confident in the potential of our promising late-stage product candidate. We are focused on evaluating the most appropriate measures to implement the FDA’s recommendations and are also preparing for near-term interactions with the EU regulatory authorities regarding D-PLEX100. We look forward to providing further clinical and regulatory updates on both U.S. and European markets.”

  • Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer